We manufacture and supply Active Pharmaceutical Ingredients (APIs) through our sites in North America, Europe, and Asia. Our API facilities have been inspected and approved by several global regulatory bodies including the US FDA, Japan PMDA, UK MHRA and meet the cGMP compliance standards.

We have a successful performance record of over 40 years of supplying APIs to the US and European markets. With the total reactor volume exceeding 500 KL (including pilot and multi-purpose plants), we are the preferred partner for big pharma and biotech across NA and Europe. We have a track record of over 30 launches and are capable of executing extensive API requirements of our clients.

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Services Offered

Manufacturing and Supply of:

  • High Potent APIs(HPAPIs)
  • Key Starting Materials (KSMs)
  • Registered Starting Materials (RSMs)
  • Key GMP Intermediates
  • Commercial scale APIs

Our capabilities

  • Flexible Containment facility
  • cGMP multi-purpose pilot plants
  • Total reactor capacity of greater than 500 KL
  • Multi-stage synthesis with continuous cost improvement
  • Micronization, filtration/drying & continuous liner pack off capability
  • Capability to handle range of reactions including:
    • High temperature de-carboxylation
    • Enzymatic reactions
    • Cryogenic reactions
    • Hydrogenation
    • Cyanation
    • Friedel-Crafts chemistry

Locations

Aurora, Canada

This is our site for development and GMP manufacturing for complex pharmaceutical NCEs. It is located in Aurora, 50 kms north of Toronto.

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Lexington, USA

The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.

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Riverview, USA

Our State-of the-Art FDA licensed cGMP facility in Riverview, USA, has over 50 years of extensive experience in delivering robust cGMP manufacturing processes..

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Grangemouth, UK

Grangemouth, UK is a USFDA and MHRA approved site dedicated to the contract development and manufacturing of Antibody Drug Conjugates since 2004.

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Morpeth, UK

The Pharma Solutions Morpeth site is one-of-a-kind US FDA and UK MHRA approved facility offering integrated services across the pharmaceutical value chain.

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Ahmedabad, India

Ahmedabad, India site was established in 2009. It is a MPA, Sweden approved and FDA approvable facility for development..

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Ahmedabad, India

Piramal Discovery Solutions site is located in Ahmedabad, India and provides a comprehensive range of early stage drug discovery services

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Mumbai, India

Operational since 2005, our Mumbai site is fully equipped for development of all liquid dosage forms both Sterile and Non-sterile.

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Pithampur, India

The Pithampur formulations site is a Greenfield project set in 1992 by Piramal Pharma Solutions. The US FDA and UK MHRA approved facility..

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Ennore, India

Ennore is identified as the India centre for development and early phase projects located near the Chennai port. The site is spread over an area of 75 acres..

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Digwal, India

It is a dedicated and multipurpose plant identified for custom manufacturing and development for late phase API’s and advanced intermediates.

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Mahad, India

It is a multipurpose plant identified for manufacturing of straight Vitamins & Vitamin Mineral Premixes.

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Aurora, Canada

This is our site for development and GMP manufacturing for complex pharmaceutical NCEs. It is located in Aurora, 50 kms north of Toronto.

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Lexington, USA

The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.

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SHANGHAI, CHINA

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Other Offerings

API Manufacturing

High Potency APIs (HPAPIs)

Finished Dosage Manufacturing

Late Lifecycle Management

We consider route scouting as a focused business to rapidly assist our partners in discovering and developing cost effective, competitively advantaged, robust chemical processes from early drug phase through commercial launch.

We provide our enzyme catalyzed processes for fast track discovery and development of novel, green & economical routes to APIs.

We have been providing pharmaceutical intermediate and API process development services for nearly three decades from our network of R&D and manufacturing facilities across the globe.

With very small quantities of active pharmaceutical ingredients (API) or drug-able candidate molecules, Piramal Pharma Solution's pre-formulation service can provide valuable information and expertise to guide the compounds to next steps.

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